VPAP AUTO WITH HUMIDAIRE 3I

K082605 · Resmed, Ltd. · BZD · Jan 13, 2009 · Anesthesiology

Device Facts

• Record ID: K082605
• Device Name: VPAP AUTO WITH HUMIDAIRE 3I
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional interrated HumidAire 3 is indication of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 3i are intended for use in the hospital and home.

Device Story

VPAP Auto System is a microprocessor-controlled blower system generating Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O; maintains 'air splint' to treat Obstructive Sleep Apnea (OSA). System comprises flow generator, patient interface, and optional integrated HumidAire 3i humidifier. Used in hospital and home settings; operated by patients or clinicians. Device features improved power supply and heater controller for humidifier compared to predicate. Clinicians/users utilize device to deliver prescribed pressure therapy; output affects airway patency during sleep, providing therapeutic benefit for OSA patients.

Clinical Evidence

Bench testing only. Design and verification activities were performed based on risk analysis and design requirements; all tests confirmed the product met predetermined acceptance criteria.

Technological Characteristics

Microprocessor-controlled blower system; CPAP range 4-20 cmH2O. Includes flow generator, patient interface, and integrated humidifier. Features improved power supply and heater controller. Complies with FDA guidance for ventilators and software.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea (OSA) in patients weighing >66 lb (30 kg). Intended for hospital and home use.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• VPAP Auto (K071171)
• Fisher and Paykel, HC604 CPAP Humidifier (K041900)

Submission Summary (Full Text)

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# 510(k) Summary - VPAP Auto System

JAN 1 3 2009

KOR26005

Date Prepared

1st Sep, 2008

P

Official Contact Dr Lionel King V.P., Quality Assurance & Regulatory Affairs ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia

| Tel: | [phone] |
|------|-------------------|
| Fax: | [phone] |

| Classification Reference | 21 CFR 868.5905 |
|--------------------------|---------------------------------------------------------------------------|
| Product Code | 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB). |
| Proprietary Name | VPAP Auto System |
| Predicate Device(s) | VPAP Auto (K071171)<br>Fisher and Paykel, HC604 CPAP Humidifier (K041900) |

Reason for submission

New Technology

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#### Indication for Use

The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional interrated HumidAire 3 is indication of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 3i are intended for use in the hospital and home.

### Substantial Equivalence

The new device has the following similarities to the previously cleared predicate devices.

- Same intended use A
- Similar operating principle
- Similar technologies A
- Same manufacturing process A

Design and Vertification activities were performed on the VPAP Auto System as a result of the risk analysis and design requirements. All tests confirmed the product met the predetermined acceptance criteria. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment for palients with Obstructive Sleep Apnoea (OSA) who weigh more than 66 lb (>30 kg). The new device complies with the applicable requirements referenced in the FDA guidance documents:

- >> FDA Draft Reviewer Guidance for Ventilators (July 1995)
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May A 11, 2005)
- >> FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)

#### Device Description

The VPAP Auto System is similar to the predicate device, (VPAP Auto with HumidAire 3 (K071171)) with a new and improved power supply and heater confroller for the HumidAire 3i. Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splin" for effective treatment of OSA. The system comprises the flow generator, patient interface) and humidifier.

The performance and functional characteristics of the VPAP Auto system includes all the clinician and user friendly features of the predicate devices.

### Conclusion

The VPAP Auto System is substantially equivalent to the Predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

JAN 1 3 2009

Re: K082605

Trade/Device Name: VPAP Auto System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 6, 2009 Received: January 8, 2009

Dear Mr. D'Cruz;

We have reviewed your Section 510(k) premarket notification of intent to market the device i referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. D'Cruz

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anton Dimockfin

Ginette Y. Michaud, M.D. Acting Division Director . Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indication for Use

510(k) Number (if known): |( 0 82 6 6 U S

Device Name: VPAP Auto System

### Indication for Use

The VPAP Auto system is indicated for the treatment of Obstructive Steep Apnea (OSA) in patients weighing more than 66 Ib (30 kg). The optional integrated HumidAire 31 is indication of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 3i are intended for use in the hospital and home.

Prescription Use _ X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

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Mel Y. Dahl

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082605